BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUPLER

    MDR report key: 8320639 · Received February 8, 2019

    Report

    Report Number
    1416980-2019-00667
    Event Type
    Injury
    Date Received
    February 8, 2019
    Report Date
    March 7, 2019
    Manufacturer
    BAXTER HEALTHCARE - SAINT PAUL - MCA
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C JALOUX, B. BETRAND, A. MAYOLY, M. CEGARRA-ESCOLANO, C. PHILANDRIANOS. MICROVASCULAR ANASTOMOTIC COUPLER: AN UNEXPECTED ADVERSE EVENT, THIEME E-JOURNALS-JOURNAL OF RECONSTRUCTIVE MICROSURGERY/ABSTRACT, OCULOPLASTIC SURGERY, THIRD EDITION, HTTPS://WWW.THIEME-CONNECT.DE/MEDIA/IRM/EFIRST/LOOKINSIDE/10-1055-S-0038-1677036-180263-1.IPG. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A 2.0MM COUPLER DEVICE WHICH WAS USED FOR AN ANASTOMOSIS BETWEEN THE ANTEROLATERAL THIGH (ALT) PEDICLE VEINS AND THE DORSALIS PEDIS VEINS. IT WAS REPORTED APPROXIMATELY NINE MONTHS AFTER THE INITIAL SURGERY, THE PATIENT COMPLAINED OF A SMALL DISCOMFORT IN THE DORSUM OF THE OPERATED FOOT. AN X-RAY WAS PERFORMED WHICH CONFIRMED THE DEVICE UNDERNEATH THE SKIN. THE REVISION SURGERY REMOVED THE DEVICE AND THE ARTERY WAS LEFT ANASTOMOSED. IT WAS REPORTED THERE WERE NO COMPLICATIONS AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115403 COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR MVR BAXTER HEALTHCARE - SAINT PAUL - MCA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention COUPLER 1.5MM